FDA WARNING_LETTER - Five Leaf Pet Botanicals, Inc. - July 25, 2023

The FDA issued a Warning Letter to Amanda A. Banting regarding the marketing of unapproved new animal drug products, including "Canine Heart Tonic, Hawthorne Tincture, Hepara-Cleanse, and Rena-Cleanse." The FDA reviewed websites www.caninehearthealth.com, www.caninekidneyhealth.com, www.canineliverhealth.com, and www.fiveleafpetbotanicals.com in March, April, and May 2023.

The products are deemed drugs under section 201(g)(1)(B) and (C) of the FD&C Act because they are intended for disease treatment or to affect animal body structure/function. Examples of claims include treating CHF, Valvular Disease, DCM, Canine Heart Murmurs, increasing heart muscle contractions, improving left ventricle ejection fraction, reducing peripheral vascular resistance, acting as a diuretic, being an antioxidant, and addressing high blood pressure, angina, cholesterol, arrhythmias, atherosclerosis, and congestive heart failure. Other claims include killing urinary infections, cleaning and repairing kidneys, removing parasites and intestinal worms, and aiding recovery from sinus, skin, and ear infections.

These products are considered "new animal drugs" under section 201(v) of the FD&C Act because they lack general recognition among experts for safety and effectiveness. They are not subject to an approved new animal drug application, conditionally approved application, or index listing under